In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures.
The agency notes that coatings may sometimes separate from intravascular devices and it has seen serious adverse events from hydrophilic and hydrophobic coatings in devices and wires.
The agency notes that several causes of coating separation have been reported but says no specific manufacturer or brand of the devices carries a higher risk of coating separation than others.
Proper device selection, adequate premarket testing and preparation are needed to reduce clinical use-related issues of devices with lubricious coatings. The guidance covers the information devicemakers should include in labeling submitted in premarket applications or premarket notification submissions for Class 2 and Class 3 devices.
The agency includes recommendations for device and coating descriptions, writing an Indications for Use statement, device-related warnings, communicating preparation steps the user should follow in the clinical setting, and providing statements of potential and known adverse effects associated with coating loss.
Read the guidance full here: www.fdanews.com/10-10-19-Coating.pdf.